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- ...Quality Assurance Batch Record Reviewer – Newtown, PA Responsible for performing tasks to specifications related to oral solid and liquid dose... ...Ensure all batch records are accounted for and transferred to the QA department. ~ Ensure all entries are entered into the...Suggested
- ...Summary: The primary responsibility of a QA Lot Review Specialist IV is the closeout of all... ...prior to the release of Production Batches. QA Lot Review Specialist IV is responsible... ...includes manufacturing batch records and ancillary documentation such as Lot...SuggestedFull timeWork at office
$98.6k - $148k
...include continuous improvement, QMS oversight, batch release process ownership, change control... ...Do : Oversee the Quality Assurance (“QA”) team, including document control.... ...process, and product. Coordinate the batch record review and approval process to ensure timely...SuggestedHourly payMinimum wageWork at officeLocal area- ...Responsible for approving and rejecting all batches # Management of Product Hold and... ...Retention Requirements # Records /Documentation review and sign off for OTC Products ~... ...of experience in Quality Management, QA, or QC. Proven expertise in Quality...SuggestedLocal areaWorldwide
- ...e.g. Change Control Committee, Deviation Review Board, CAPA Board Conducts regularly... ...testing is carried out and the associated records evaluated To lead the method... ...approval of certificate of Analysis to support batch release Ensure that product has been...SuggestedFor contractors
- ...including manufacturing processes, controlled areas, critical utilities (e.g. WFI, Steam, Automation, equipment, HVAC, etc.), and batch record review. Incumbent provides technical expertise on GMP equipment and Quality Assurance standards and processes to team members....Suggested
- ...work with/through Magnit at Novartis? Please read on... QA Associate 1 shift - Sun -Wed 9AM - 5PM (x1) 2 shift -... ...within the PU, QC labs, and other support area. ensure timely review of batch record for materials as instructed (e.g. media, apheresis, etc.)...SuggestedContract workTemporary workFor contractorsShift work
- ...QA Associate The QA Associate is responsible for the rigorous review, verification, and archival of batch records and associated documentation to ensure compliance with internal SOPs, cGMP, and FDA regulations. This role is primarily desk-based and involves close collaboration...SuggestedContract workTemporary workWork at officeMonday to FridayFlexible hoursDay shift
- ...youll serve as the on-the-floor QA presence supporting... ...room and equipment clearance, review documentation, and help ensure... ...rooms and equipment prior to batch operations. Conduct in-process... ...production activities. Receive and record external samples within...SuggestedPart time
$65k - $72.5k
...business in the United States. Job Title QA Validation Associate II Organization... ...but are not limited to GMP documentation review and supporting other QA functions as... ..., including but not limited to: executed batch records, master batch records, product labels, and...SuggestedHourly payFull timeTemporary workRemote workFlexible hoursShift work$55k - $65k
...QA Specialist II at Pace Analytical Life Sciences summary: The QA Specialist II... ...knowledge and skills. Overseeing , reviewing, writing, updating, completing, and... ...includes, but is not limited to manufacturing batch records, technical records, pertinent laboratory...SuggestedFull timeWork at officeLocal areaImmediate startMonday to FridayFlexible hoursShift work- ...pharmacy standards. This role oversees all Quality Assurance (QA), regulatory compliance, and sterile manufacturing oversight,... ..., state boards of pharmacy, and third parties. Oversee batch record review, release, and disposition for compounded sterile products (...SuggestedFull timeMonday to Friday
- ...pharmaceutical manufacturing, is seeking a QA Associate to join their... .... Functions include document review, TrackWise reporting, hold... ...Evaluation of raw material records and testing records Disposition... ...of raw materials and bulk batches per associated specifications....SuggestedLong term contractContract workFlexible hours
- ...Job Description Duration : 12 Months Description: QA Shop Floor - 3rd shift Must be able to work four 10 hour days... ...Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations...SuggestedLocal areaNight shift
$170.66k - $316.94k
...area of responsibility, e.g. batch release. You will identify timeline... ...carry out employee appraisal reviews including performance... ...professional experience with operational QA responsibilities in high-... ...of working. A consistent track record to perform against tight...SuggestedFull timeWork at officeLocal areaRelocation package- ...oriented, and proactive Quality Assurance (QA) Specialist or Manager with a strong... ...0, Part 312, and Part 11 (Electronic Records), as applicable. Review Good Clinical Laboratory Practice (... ...that study documentation (e.g., batch records, raw data, final reports) meets...Full time
- ...91320 Employment Type: Contract Business Unit: Plant QA Drug Substances Duration: 18+ months (with likely extensions... ...include purposeful presence on the manufacturing floor, batch record review, SOP and MP revision approval, work order approval, and quality...Contract workShift workNight shiftDay shiftAfternoon shift
- ...EMA, GMP). As a liaison between the company and our contract manufacturing organization (CMO), the QA Manager will manage quality systems, review and approve batch records, handle deviations, and ensure proper documentation practices. Key Responsibilities:...Contract work
- ...program. Responsible for document management (e.g., Master Batch Record, protocol Review and approve quality system records in Trackwise... ...) ~10+ years’ experience in a Manufacturing environment, QA, Quality Systems, and/or Compliance experience in a cGMP/FDA...Work at office
- ...operations. Key Responsibilities Issue batch records in alignment with the production schedule... ..., and preventive maintenance records. Review and evaluate Environmental Monitoring (EM... ...activities in ProCal. Perform QA review and approval of non-routine workorders...
$102.5k - $108k
...Assurance this position is responsible for batch release for commercial product to the... ...to this job at any time. Reviews batch records and oversees the process to release batches... ...ensure adequate line coverage support from QA. Evaluate, analytes and trends...Full timeContract workShift work$165k - $200k
...products for use in clinical and commercial operations. Manage batch record review, product investigations, deviations, complaints, change... ...Review and update GMP related SOPs and policies Serve as QA representative on departmental and project team(s) representing...Contract workWork at officeLocal area- ...Summary The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy... ...incidents. Controlled issuance of batch records in preparation for manufacturing. Perform review of manufacturing batch records in preparation for...Immediate startShift work
$165k - $200k
...products for use in clinical and commercial operations. Manage batch record review, product investigations, deviations, complaints, change... ...Review and update GMP related SOPs and policies Serve as QA representative on departmental and project team(s) representing...Full timeContract workFor contractorsWork at officeLocal areaWork visa- ...sciences. We are currently seeking an ambitious Sr. QA Specialist-3 to join our dedicated team in... ...Systems. Key responsibilities: Review and approve initial and revised documents such as SOPs, Master Batch Records, Work Instructions, Test Methods, Specifications...Full time
- ...the highest ethics standards for the following position: ~ QA Specialist I General Position Summary/Purpose: Purpose... ...The QA Technical Services Specialist is responsible for QA batch record review and disposition assuring that bulk and finished products...Monday to Friday
- ...be a hands-on Director who brings broad QA experience in the biologics industry.... ...authority regulations and industry guidance Review all GXP documents/reports especially as... ...quality agreements) and manage GMP product batch record review and disposition. Lead and...Full timeFor contractorsWorldwide
- ...consultants for specialized technical QA functions while ensuring... ...preferred. ~ Strong track record managing QA systems, vendor oversight... ..., and ongoing monitoring. Review and approve quality-related... ...documentation (e.g., protocols, reports, batch records, SOPs, deviation/CAPA...Full time
- ...Quality Assurance serves as an additional QA in-house subject matter expert on GxP... ...Supports IND and NDA CMC module authoring, review and QC, supports responses to requests for... ...Responsible for supporting Quality Operations in Batch record review, OOS, deviations, change controls...Local area3 days per week
- ...Base pay range $92,000.00/yr - $116,000.00/yr Responsibilities Perform QA on-the-floor batch record review responsibilities including in-process batch record review, execution of QA walkthroughs, performance of line clearance, and in-process / final product...Full time